NeuroStar TMS Therapy SystemRecalls & reported problems across all models
Neuronetics, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls
- 0
We found 2 models of NeuroStar TMS Therapy System by Neuronetics, Inc. in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2022 and Apr 16, 2026 — classified as 60 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NeuroStar TMS Therapy System problems
Device problems
- Adverse Event Without Identified Device or Use Problem34
- Patient-Device Incompatibility10
- Insufficient Device Problem Information6
- Patient Device Interaction Problem4
- Improper or Incorrect Procedure or Method3
- Appropriate Device Problem Term/Code Not Available2
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Convulsion/Seizure20
- Headache16
- Tinnitus9
- Depression6
- Suicidal Ideation6
- Anxiety5
- Emotional Changes4
- Fatigue4
NeuroStar TMS Therapy System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NeuroStar TMS Therapy System NeuroStar 3.0 USTranscranial Magnetic Stimulator58 reports
- NeuroStar TMS Therapy System NeuroStar 2.0 USTranscranial Magnetic Stimulator2 reports
Recent NeuroStar TMS Therapy System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
PATIENT EMAILED THE PRACTICE AND NNI DIRECTLY BUT SEPARATELY REGARDING A VERY LONG LIST OF COMPLAINTS THAT HE FELT ARE RELATED TO TMS TREATMENT. THE PATIENT LISTED A LARGE NUMBER OF ISSUES WHICH WHEN REVIEWED SHOWED A WORSENING OF OCD AND POSSIBLY MDD SYMPTOMS WHICH APPEAR TO HAVE STARTED AFTER HAVING OCD ADDED TO THE MDD TREATMENT.
Patient problems: Emotional Changes
MAUDE report 24903600 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT DEVELOPED A SEVERE, PERSISTENT HEADACHE THAT HAS NOW BEEN PRESENT INTERMITTENTLY SINCE (B)(6) 2026.
Patient problems: Headache
MAUDE report 24808663 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
A PRACTICE REPORTED THAT A CURRENT TMS PATIENT PRESENTED FOR TREATMENT STATING THAT SHE WAS EXPERIENCING NIGHTMARES, VISION DISTORTION, SEEING OBJECTS THAT AREN'T THERE, AND LOUD NOISES BECOMING BOTHERSOME. SHE WANTED TO KNOW IF THESE THINGS WERE COMMON SIDE EFFECTS, WHICH THEY ARE NOT.
Patient problems: Cognitive Changes; Depression; Dizziness; Fatigue; Hallucination; Headache; Memory Loss/Impairment; Sleep Dysfunction; Unspecified Gastrointestinal Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Nervous System Problem
MAUDE report 24680807 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
THE PROVIDER REPORTED THAT A PATIENT ON THEIR 12TH OCD/MDD TMS SESSION WAS EXPERIENCING BILATERAL HIGH FREQUENCY TINNITUS THAT HAD BEEN UNREMITTING FOR SEVERAL DAYS.
Patient problems: Tinnitus
MAUDE report 24378731 ↗InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem
PATIENT ATTEMPTED SUICIDE IN THEIR HOME. THE PRACTICE NOTED THAT THE PATIENT HAD WORSENING ANXIETY, OCD, AND SUCIDAL IDEATION PRIOR TO THE ATTEMPT, BUT THEIR LAST DEPRESSION SCORES DID NOT WORSEN ABOVE THEIR BASELINE SCORE.
Patient problems: Convulsion/Seizure
MAUDE report 24298899 ↗InjuryJan 12, 2026Patient-Device Incompatibility
THE PATIENT NOTIFIED THE TMS PROVIDER'S OFFICE THAT THEY HAVE BEEN EXPERIENCING WORSENING MIGRAINES SINCE ENDING TMS TREATMENT 6 MONTHS AGO.
Patient problems: Headache
MAUDE report 24038320 ↗InjuryDec 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT COMPLAINED OF HEARING LOSS ABOUT 10 HOURS AFTER RECEIVING HER 5TH TMS TREATMENT. PATIENT WAS NOT OFFERED HEARING PROTECTION AND DID NOT WEAR ANY. ENT DETERMINE THE PATIENT HAD MILD TO MODERATE HEARING LOSS AT TWO FREQUENCIES.
Patient problems: Partial Hearing Loss
MAUDE report 23885903 ↗InjuryAug 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECEIVED A NEGATIVE COMMENT FROM THE COMPANY'S SOCIAL MEDIA MONITOR ALLEGING THAT TMS CAUSED WORSENING TINNITUS.
Patient problems: Tinnitus
MAUDE report 22922592 ↗InjuryAug 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECIEVED INFORMATION FROM A PRACTICE THAT A PATIENT WAS EXPERIENCING WORSENING DEPRESSION, INCREASED IRRITABILITY, AND SUICIDAL IDEATION AFTER TREATMENT SESSION NUMBER 8. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOR THE SUICIDAL IDEATION.
Patient problems: Depression; Suicidal Ideation
MAUDE report 22899690 ↗InjuryAug 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECEIVED A MEDWATCH FROM FDA (MW5172397) ALLEGING THAT A PATIENT RECEIVED TMS (NEUROSTAR) TREATMENT IN 2023 RESULTED IN RECURRING, UNILATERAL MIGRAINES ON THE SAME SIDE THAT SHE WAS TREATED WITH TMS. ADDITIONALLY, THE PATIENT ALLEGES THAT SHE HAS A TIC ON THE LEFT SIDE OF HER FACE, WHICH IS A COMMON SIDE-EFFECT OF A DRUG SHE WAS TAKING AT THE TIME OF HER TMS TREATMENT. HOWEVER, AFTER STOPPING THE DRUG, THE TIC REMAINED. THE REPORTER STATES THAT SHE "CAN'T CONFIDENTLY ATTRIBUTE ALL THE MIGRAINES TO TMS..." AND THERE IS NO INFORMATION THAT SHE HAS RECEIVED A DIAGNOSIS FROM A NEUROLOGIST.
Patient problems: Headache; Tics/Tremor
MAUDE report 22865918 ↗InjuryJul 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED TO NEURONETICS THAT SHE HAD EXPERIENCED DEBILITATING MIGRAINES, WORSENING DEPRESSION AND SUICIDAL IDEATION AFTER RECEIVING TMS TREATMENTS. THE PATIENT DISCONTINUED TREATMENT AFTER HER 10TH SESSION.
Patient problems: Emotional Changes; Headache; Suicidal Ideation
MAUDE report 22571349 ↗InjuryJul 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECEIVED AN EMAIL FROM A NEUROSTAR PATIENT THAT REPORTS RINGING IN HER EARS AND HEADACHES AFTER SEVERAL TMS TREATMENT SESSIONS.
Patient problems: Headache; Tinnitus
MAUDE report 22570614 ↗InjuryJul 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
NEURONETICS WAS MADE AWARE OF NEGATIVE COMMENTS, ON A NEUROSTAR POST, BY THE COMPANY'S SOCIAL MEDIA MONITOR INCLUDING ONE THAT ALLEGED THAT TMS TREATMENT CAUSED (NONSPECIFIC) EYESIGHT ISSUES AND CHRONIC MIGRAINES.
Patient problems: Headache; Unspecified Eye / Vision Problem
MAUDE report 22470844 ↗InjuryJun 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECEIVED A CALL FROM A FORMER TMS PATIENT THAT ALLEGES SHE STARTED HAVING SEIZURES ABOUT 5 MONTHS (MARCH 2025) AFTER HER TREATMENT ENDED IN OCTOBER OF 2024. SHE STATED HER FIRST EPISODES REQUIRED HOSPITALIZATION FOR 3 DAYS.
Patient problems: Convulsion/Seizure
MAUDE report 22366455 ↗InjuryJun 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
NEURONETICS WAS MADE AWARE OF NEGATIVE COMMENTS, ON A NEUROSTAR POST, BY THE COMPANY'S SOCIAL MEDIA MONITOR INCLUDING ONE THAT ALLEGED THAT TMS TREATMENT CAUSED ANOSMIA (SENSE OF SMELL LOSS).
Patient problems: Hyporesponsive to stimuli
MAUDE report 22353255 ↗
Other Neuronetics, Inc. products
All Neuronetics, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page